Bone Graft Device named Infuse

A Senate Finance Committee investigation has revealed that Medtronic Inc., the world’s largest medical device manufacturer, actively engaged in deception and fraud concerning the marketing of its bone graft device InFuse. According to reports, Medtronic secretly hired private consultants to write and edit phony medical journal articles about the $800 million-a-year device, which was meant to give the illusion that these articles were written by independent scientists and physicians.

The committee determined that Medtronic failed to disclose its role in crafting the 13 key studies that made InFuse the “blockbuster” medical device it is today, which included dispensing roughly $210 million to the consultants responsible for authoring and doctoring many of them. The report also found that the company actively downplayed the risks associated with InFuse, which include things like male sterility, serious infection, and chronic pain in the back and legs.

“Medtronic’s actions violate the trust patients have in their medical care,” said Sen. Max Baucus (D-Mont.) in a statement about the issue. “Medical journal articles should convey an accurate picture of the risks and benefits of drugs and medical devices, but patients are at serious risk when companies distort the facts the way Medtronic has.”

While doctors and surgeons are free to use both pharmaceutical drugs and medical devices for off-use purposes as they see fit, medical device and drug companies themselves are prohibited from marketing their products for off-label uses. This is another area where Medtronic is in hot water, as its company-funded journal articles insinuated benefits for various off-label uses of InFuse, many of which have been deemed dangerous by federal health authorities.

Earlier in the year, the Department of Justice (DOJ) concluded its own four-year investigation into the shady marketing tactics of Medtronic for InFuse. Besides secretly authoring studies and peddling them off as independent research, Medtronic also tried to posit its device as safer and less painful than other bone graft alternatives, deliberately hiding data about the device’s potentially deadly side effects in the process.

Those named in the committee report as conspiring with Medtronic to create the fraudulent articles include Dr. Ensor Transfeldt of Twin Cities Spine Center in Minnesota. According to StarTribune.com, Transfeldt was paid more than $3.5 million between 1996 and 2010 for his services, while Inspire LLC, a group own by Transfeldt and several others, was paid $2.9 million.

“[P]hysician authors who had financial ties to Medtronic failed to report dangerous side effects associated with InFuse,” says the committee report. “These dangerous side effects were subsequently reported by medical researchers that did not have financial relationships with the company.”